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Outsourced Development
Allura Medical Solution, Inc. has devised and attuned close to perfection the complete process of development of medical tools and devices, starting with exploring the empty niche needed to be filled to conceptualization of ideas and up to engineering and development of prototype ready to be put into production.
Allura Medical Solution, Inc. has devised and attuned close to perfection the complete process of development of medical tools and devices, starting with exploring the empty niche needed to be filled to conceptualization of ideas and up to engineering and development of prototype ready to be put into production.
- OS / NS Implant System
- Spinal System
- Trauma System
- Dental Implant & Tool System
- Special Instruments
- General Instruments
The list of our services includes, but not being limited to, matching the product description to the most appropriate design specifications, creating a general concept, developing a particular device/process, prototyping, bio-compatibility check, V/V tests, internal quality control, validation and regulatory compliance support prior to start of mass production.
The list of our services includes, but not being limited to, matching the product description to the most appropriate design specifications, creating a general concept, developing a particular device/process, prototyping, bio-compatibility check, V/V tests, internal quality control, validation and regulatory compliance support prior to start of mass production.
- Based on 21 CFR 820.30 & ISO 13485:2016
- Build up DHF Structure
- §Review Design Control Records
- Documentation & Record Acquisition
- Integrity of Design Control Records & Quality System Records
- Current Engineering
- Risk Management & Design Controls
- Quality System & Design Controls
- Manufacturing & Design Controls
- Risk Management
- Management of Design Change Records
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